RegWardenFDA facility compliance records
Recall

Class II — In2Bones, SAS

Recalling firmIn2Bones SAS
Registered facilityIn2Bones SAS (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonThis Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
ProductI.B.S® 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
Quantity63 units
DistributionUS Nationwide distribution in the state of Tennessee.
Initiated2024-01-26
Classified2024-03-20
Recall numberZ-1320-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — In2Bones, SAS (Z-1320-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94063/

Not open yet

Alerts for In2Bones SAS

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.